Cleared Traditional

Element System with IBT Electrodes (K173571) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173571 · Infinite Biomedical Technologies, LLC · Neurology device
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Mar 2018
Decision
121d
Days
Class 2
Risk

K173571 is an FDA 510(k) clearance for the Element System with IBT Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Infinite Biomedical Technologies, LLC (Baltimore, US). The FDA issued a Cleared decision on March 21, 2018 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Infinite Biomedical Technologies, LLC devices

Submission Details

510(k) Number K173571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2017
Decision Date March 21, 2018
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K173571.
EEG-Now
K180524 · Encephalodynamics, Inc. · May 2018
NeuroCap
K172866 · Memory MD, Inc. · Apr 2018
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
K172887 · Guangzhou Xinbo Electronic Co., Ltd. · Apr 2018
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
K173186 · Everyway Medical Instruments Co.,Ltd · Feb 2018
Electrodes with snap / Electrodes with pigtail
K171722 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
Electrodes with silver conductive
K171721 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018